<p>Job overview:</p> <p>The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements.</p> <p>Location: Hybrid in our NYC Office or remote in the East Coast.</p> <p>Reports to: Associate Director, Statistics and Data Management.</p> <p>Duration: 9-month contract.</p> <p>Roles and Responsibilities</p> <p>(Include but are not limited to):</p> <ul> <li>Leading and coordinating the programming activities within agreed timelines </li><li>Managing the reporting of studies internally and externally </li><li>Programming outputs as stated in the analysis plan </li><li>Working closely with study team members, mainly with the study statistician </li><li>Reviewing of the Statistical Analysis Plan (SAP) and shells </li><li>Create and review SDTM and ADaM study specifications </li><li>Ensure programs, datasets, outputs are appropriate for regulatory submission </li><li>Perform simulations and data modelling </li><li>Perform Interim analyses </li><li>Liaise with external vendors on deliverables </li></ul> <p>Candidate Profile:</p> <ul> <li>Extensive years experience in statistical programming </li><li>CDISC expertise </li><li>Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R </li><li>Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting </li><li>Experience in performing quality control (QC) checks </li><li>Extensive knowledge in regulatory submission process </li><li>Good understanding of ICH guidelines and regulations such as 21 CFR Part 11 </li><li>Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions </li><li>Ability to solve challenging problems and provide recommendations to mitigate risk </li><li>Good communication skills - both written and verbal </li><li>Team work skills - Including cross-functional and within the Statistics and Data Management Team </li></ul>